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ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
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The system validation lifecycle refers to the full, structured process of validating a computerized system, such as an EBR or MES, from initial planning and requirements definition, through installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), to ongoing maintenance and eventual system retirement.
Following a defined validation lifecycle ensures a system isn't just tested once at go-live and forgotten, but is maintained in a validated state throughout its operational life, including managing the impact of software updates, configuration changes, and periodic reviews.
After a vendor releases a software update to the EBR platform, the validation team follows the established lifecycle process to assess the change's impact, re-validate affected functionality, and document the update before it's deployed to the production environment.
No. Validation is an ongoing lifecycle responsibility; systems require periodic review, and any subsequent changes or updates need their own impact assessment and re-validation as appropriate.
Installation Qualification confirms the system is installed correctly; Operational Qualification confirms it operates as intended across its specified range; Performance Qualification confirms it performs consistently under actual production conditions.
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